Development of Antibody-Based Therapeutics

Development of Antibody-Based Therapeutics: Translational Considerations examines important considerations necessary for the design of effective translational strategies during the development of antibody-based therapeutics. Translational strategies for development of antibody-based therapeutics require an understanding of the relationship between the unit dose and unit effect with respect to both beneficial and deleterious biological effects from early stages of development. The flow of information across various stages of development should provide opportunities to facilitate selection of more effective novel and next-generation drug candidates. Successful strategies for the development of monoclonal antibodies require integration of knowledge with regards to target antigen properties in health and disease, as well as antibody design criteria including affinity, isotype selection, pharmacokinetics/pharmacodynamics (PK/PD) properties, antibody cross-reactivity across species, and safety. Selection and evaluation of appropriate biomarkers in early preclinical development in relevant animal models should allow identification of potential risks and liabilities of an antibody drug candidate to humans and establishment of safe First-In-Human (FIH) dosing strategies. This volume provides a comprehensive review of the topics critical for establishing successful translational strategies for the development of antibody-based therapeutics.